Calibration Interval calculation for ECG Machine

subbash

Involved In Discussions
#1
Hi,

I am working on finding the calibration interval for our ECG Device. Can anyone suggest the process that has been used.

I am reviewing the guideline document from ILAC which details different approaches.

Can we use the number of ECG Records captured on the device and set a threshold. Based on the threshold set we can set the initial interval. After subsequent calibration cycles, We can use the calibration result to adjust the calibration interval. Is this approach okay to be used.

To support the initial calibration interval I am planning to use the MTBF Value that is generated too.

Thanks
 
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Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
Hello subbash,

I certainly support using past calibration performance to help decide and/or alter calibration frequency. I hope you are planning to track drift instead of failures, as risking gauge failure through extended calibration cycles seems non-productive. This is why I am not sure about using MTBF for determining calibration, although some organizations support it. NIST suggests using control chart-type tracking as one factor in the decision. I agree with NIST.

Do the instruments' manufacturers recommend a cycle time frame? I tend to see their recommendations on the short side, perhaps out of caution but they don't know what the cost of failure would be.

I am not affiliated with Brooks Instrument.
 

subbash

Involved In Discussions
#3
Dear Jen,

Thanks for the suggestions. Yes We are planning to track the drift. To do that, We are planning to measure the performance of the devices from the period first batch was shipped out till now.

For example, If the first batch of devices were shipped in 2016. We are planning to verify sample of 2 or 3 devices each year. For example. 2 devices which are in field for 5 years, 2 devices which are in field for 4 years and so on upto the device which has been in field for 1 year.

So this would help us to understand the variation in the device performance. Is this plan fine or do you have any other suggestions.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#4
Hi subbash,

I don't understand how your plan measures drift in measurement devices. Ideally, the only variable would be your measurement device. It would be measuring NIST traceable standards repeatedly (hopefully the same exact standards) so the only thing that changes is the results shown by your calibrated instrument.

In other words, remember what you are studying: the instrument, not the product over time.
 

Welshwizard

Involved In Discussions
#5
Hi, measure the same reference artefact periodically, arrange the observations in time series order on an Individual moving Range Chart and assess for consistency. Consider a signal on the chart as a prompt to adjust the device.

Run a pilot first, you may not like what you see.
 
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